Combination Products
I am wondering if there are any forums on Combination Products. If not, would it be possible creating a Division on these type of products? I would volunteer on this effort as I have been working as a Biomedical Auditor with these and have seen the need to have more discussions on the implementation of Quality Systems adhering to related regulations and guidance documents.
Best wishes for an improved New Year 2021!
13 Replies
Hi Maria!

What a great question!  The Medical Device Division has many members that have worked with combination products at one time or another.  I am sure many would be interested in a forum of sorts.

ASQ sponsors technical communities of complimentary interests.  Take a look at the Healthcare Quality And Improvement Committee (link), which is a collaboration between the Healthcare Division and the Quality Management Division.  This group has an intriguing mission and has produced papers and monographs.  Would you be interested in starting a similar collaboration with the Food, Drug, and Cosmetic Division?  Or are you picturing something completely independent?

2021 is going to be an awesome year!  Thank you for your contribution!

      Lisa Grosskopf, Chair, Medical Device Division
Hi Lisa!

Thank you for replying to my post. Based on the description of the Healthcare Quality and Improvement committee, I would propose starting a similar collaboration between the Medical Device and the Food, Drug and Cosmetic Division (as the last one covers Drugs). What do you think? I will be happy to collaborate on this.  
Best Always.
Hello again!

This may be the second reply--it appears my earlier message may have gotten lost.

I will reach out to Tim Parrent, the Chair of the FD&C Division, and see if he has Pharma members willing to support this effort.  Please start talking to your peers and see if you can get collaboration help.  I will also ask David Manalan, our Newsletter Editor, to include an article in our next newsletter describing this effort.  Would you be willing to pen an article or a request for volunteers?

Look forward to hearing from you again!

Hello Maria!

I have heard from the Chair of the FD&C Division. He said that some of his members are interested in this alliance if the scope is broader and inclusive of other industries. Are you still interested in meeting with these people so you guys can discuss and determine how you'd like to proceed?

Hi Lisa,
Sorry for replying until now. I could not find the chain of this conversation. I am still interested on this collaboration. I can pen an article if you please provide guidance on rules for writing articles. I would provide a brief introduction to combination products, and focus on the combination of Medical Device/Drugs, and Medical Device/Biologic. I was thinking to start, on asking members of both divisions what they would be interested on learning about these products and we can go from there. I think that an area of interest may be the implementation of Quality Systems for managing these products as they have different regulatory requirements. What do you think?
I think this is fabulous! Would you mind if I gave Tim Parrent (FD&C Chair) your contact info? We will set up a meeting to kick off discussion and start planning.
Hi Lisa,
Of course, you may share my contact information. I also accepted the meeting invitation you sent me. I have a colleague who is also interested on joining our team. She is in the process of joining the Medical Device Division. Looking forward to meeting with you and any other member!
Hola Maria! Great question, and I volunteer as well! Happy new year!
Hi Tamira!

Sweet! We are scheduling our first planning meeting for next week. Would you be interested in attending?

Hola Tamira! Welcome aboard! it will be great having you collaborating with us on this effort. Hope you can attend our first meeting :)
Well, hello to my former colleagues, Maria & Lisa. It's great to see you both here and the initiative you're taking on this. Let me know if I can be of any assistance, as I have some experience with combo devices. When is your meeting scheduled for? I look forward to hearing from you both.

Hey Jorge!

It's been a very long time, hasn't it?

Our first meeting will be this coming Monday at 1 pm PST. Would you like me to forward an invitation to you?

Hi Lisa, yes, please send me the invite. I'm looking forward to it...send it to